Trial Outcomes & Findings for SIB-Time Web-application Tool for Typically Developing Siblings (NCT NCT04633473)
NCT ID: NCT04633473
Last Updated: 2024-07-05
Results Overview
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) Parent/Child Relationship subscale measures the quality of the parent-child relationship, asking how true various statements have been over the past 4 weeks. The Parent/Child Relationship subscale is measured with 5 items, answered on a 5-point scale (0=Not at all; 4=Very much). Average scores range from 0 to 4, with higher scores indicating worse outcomes.
COMPLETED
NA
43 participants
Enrollment, and at 4 weeks (after treatment completion)
2024-07-05
Participant Flow
Participants were parents who were enrolled between 6/9/21 and 3/30/22. Participants were recruited through Advisory Board contacts, and social media.
Participants were parents who were enrolled in the study. Parents completed study measures. Parents engaged in activities with their child, but children were not enrolled and no data were collected from children.
Participant milestones
| Measure |
SIBTime
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parents used the dual-language SIBTime app with their children. They watched video stories about common sibling experiences, responded to question prompts, tracked connection routines, and listened to guided ACT exercises for parents. During the 4-week intervention period, they used the app at their convenience.
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|---|---|
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Overall Study
STARTED
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43
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Overall Study
COMPLETED
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37
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Overall Study
NOT COMPLETED
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6
|
Reasons for withdrawal
| Measure |
SIBTime
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parents used the dual-language SIBTime app with their children. They watched video stories about common sibling experiences, responded to question prompts, tracked connection routines, and listened to guided ACT exercises for parents. During the 4-week intervention period, they used the app at their convenience.
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|---|---|
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Overall Study
Withdrawal by Subject
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6
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Baseline Characteristics
SIB-Time Web-application Tool for Typically Developing Siblings
Baseline characteristics by cohort
| Measure |
SIBTime
n=43 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parents used the dual-language SIBTime app with their children to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided ACT exercises for parents. During the 4-week intervention period, parents used the app at their convenience.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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42 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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11 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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31 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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26 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
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Region of Enrollment
United States
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43 participants
n=5 Participants
|
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Parent Demographic Form
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43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) Parent/Child Relationship subscale measures the quality of the parent-child relationship, asking how true various statements have been over the past 4 weeks. The Parent/Child Relationship subscale is measured with 5 items, answered on a 5-point scale (0=Not at all; 4=Very much). Average scores range from 0 to 4, with higher scores indicating worse outcomes.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale
Pretest
|
0.26 score on a scale
Standard Deviation 0.32
|
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Parenting & Family Adjustment Scales (PAFAS) Parent/Child Relationship Subscale
Posttest
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0.26 score on a scale
Standard Deviation 0.35
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PRIMARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale
Pretest
|
1.17 score on a scale
Standard Deviation 0.71
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Parenting & Family Adjustment Scales (PAFAS) Parental Adjustment Subscale
Posttest
|
1.07 score on a scale
Standard Deviation 0.64
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PRIMARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Parenting \& Family Adjustment Scales (PAFAS; Sanders et al., 2014) measures change in parenting practices, family cohesion, parent-child relationship quality, and parents' stress. The 30 items on the PAFAS sort into 7 subscales: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. Items are rated on a 5-point scale (0-4) with higher scores worse.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale
Pretest
|
0.99 score on a scale
Standard Deviation 0.59
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Parenting & Family Adjustment Scales (PAFAS) Family Relationships Subscale
Posttest
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0.94 score on a scale
Standard Deviation 0.58
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PRIMARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Emotional Availability subscale measures parents' self-efficacy for providing emotional support to their typically developing child and meeting their child's emotional needs. Parents rate their agreement or disagreement with a series of statements. The SEPTI Emotional Availability subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale
Pretest
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2.07 score on a scale
Standard Deviation 0.69
|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Emotional Availability Subscale
Posttest
|
1.93 score on a scale
Standard Deviation 0.51
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PRIMARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Nurturance/Valuing/Empathic Responsiveness subscale measures parents' self-efficacy for providing empathy, nurturance, and understanding to their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Nurturance/Valuing/Empathic Responsiveness subscale is measured with 8 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale
Pretest
|
1.93 score on a scale
Standard Deviation 0.50
|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Nurturance/Valuing/Empathic Responsiveness Subscale
Posttest
|
1.75 score on a scale
Standard Deviation 0.37
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PRIMARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Play subscale measures parents' self-efficacy for playing with and having fun with their typically developing child. Parents rate their agreement or disagreement with a series of statements. The SEPTI Play subscale is measured with 7 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale
Pretest
|
2.98 score on a scale
Standard Deviation 1.17
|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Play Subscale
Posttest
|
2.64 score on a scale
Standard Deviation 0.89
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PRIMARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Self-Efficacy for Parenting Tasks Index (SEPTI; Coleman \& Karraker, 2000) - Teaching subscale measures parents' self-efficacy for explaining things and teaching their typically developing child about the world in a way that their child can understand. Parents rate their agreement or disagreement with a series of statements. The SEPTI Teaching subscale is measured with 9 items. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale
Pretest
|
2.39 score on a scale
Standard Deviation 0.74
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Self-Efficacy for Parenting Tasks Index (SEPTI) Teaching Subscale
Posttest
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2.23 score on a scale
Standard Deviation 0.68
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PRIMARY outcome
Timeframe: Week 4Population: Primary parents of a child with a disability and a preschool age typically developing child.
The System Usability Scale (SUS) is a commonly used 10-item measure (with a 5-point scale) of subjective perceptions of technology usability. To calculate the total SUS score, the responses to all 10 SUS questions are re-scaled and/or re-scored in a way that all items had values from zero to 4 with 4 being the most positive. These converted scores are added and then multiplied by 2.5 to convert the range of possible values 0-100 (instead of from 0 to 40). Higher scores are better.
Outcome measures
| Measure |
SIBTime
n=34 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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System Usability Scale (SUS)
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81.99 score on a scale
Standard Deviation 14.47
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SECONDARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Engagement in Target Activities with Child - Frequency subscale measures the frequency with which parents report engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors. Respondents answer on a 7-point frequency scale (0=Never in the past month; 6=6 or more times per day); average scores range from 0 to 6, with higher scores indicating better outcomes.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Engagement in Target Activities With Child - Frequency
Pretest
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3.62 score on a scale
Standard Deviation 0.80
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Engagement in Target Activities With Child - Frequency
Posttest
|
3.88 score on a scale
Standard Deviation 0.87
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SECONDARY outcome
Timeframe: Enrollment, and at 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
The Engagement in Target Activities with Child - Self-Efficacy subscale measures parents' self-efficacy for engaging in specific "connection routine" activities with their typically developing child in the past month, across 17 items reflecting a range of program-targeted parenting behaviors. Respondents answer on a 10-point scale of how confident they are that they can carry out these behaviors (1=Not at all confident; 10=Highly confident); average scores range from 1 to 10, with higher scores indicating better outcomes.
Outcome measures
| Measure |
SIBTime
n=37 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Engagement in Target Activities With Child - Self-efficacy
Pretest
|
7.65 score on a scale
Standard Deviation 1.46
|
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Engagement in Target Activities With Child - Self-efficacy
Posttest
|
8.56 score on a scale
Standard Deviation 1.10
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SECONDARY outcome
Timeframe: At 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
Outcome measures
| Measure |
SIBTime
n=43 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Family Usage of the SIBTime App - Number of Sessions
|
5.6 Number of sessions
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: At 4 weeks (after treatment completion)Population: Primary parents of a child with a disability and a preschool age typically developing child.
Measure the families' usage of the SIBTime app using metrics and transcripts collected on the back-end database, including activation of the app; which elements are accessed; frequency, timing, and duration of engagements; and points of difficulty or failure.
Outcome measures
| Measure |
SIBTime
n=43 Participants
43 primary parents were assessed at enrollment, then provided the dual-language, media-enhanced SIBTime technology for 4 weeks, and then re-assessed at 4 weeks (after treatment completion).
SIB-Time Web-Application Tool: Parent-child dyads used the dual-language SIBTime app to watch video stories about common sibling experiences, respond to question prompts, track connection routines, and listen to guided Acceptance and Commitment Therapy (ACT) exercises for parents. During the 4-week intervention period, families used the app at their convenience.
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|---|---|
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Family Usage of the SIBTime App - Program Exposure
|
69.9 Percentage of program exposed to
Standard Deviation 34.3
|
Adverse Events
SIBTime
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jessie Marquez
Oregon Research Behavioral Intervention Strategies
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place